Pantoprazole Mylan Pharmaceuticals 20mg Gastro-resistant Tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

PANTOPRAZOLE

Tersedia dari:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Kode ATC:

A02BC02

INN (Nama Internasional):

PANTOPRAZOLE 20 mg

Bentuk farmasi:

GASTRO-RESISTANT TABLET

Komposisi:

PANTOPRAZOLE 20 mg

Jenis Resep:

OTC

Area terapi:

DRUGS FOR ACID RELATED DISORDERS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-03-11

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE MYLAN PHARMACEUTICALS 20 MG GASTRO-RESISTANT TABLETS
(PANTOPRAZOLE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
-
You should not take this medicine for more than 4 weeks without
consulting a doctor.
WHAT IS IN THIS LEAFLET:
1.
What Pantoprazole is and what it is used for
2.
What you need to know before you take Pantoprazole
3.
How to take Pantoprazole
4.
Possible side effects
5.
How to store Pantoprazole
6.
Contents of the pack and other information.
1.
WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR
Pantoprazole contains the active substance pantoprazole, which blocks
the ‘pump’ that
produces stomach acid. Hence it reduces the amount of acid in your
stomach.
Pantoprazole is used for the short-term treatment of reflux symptoms
(for example heartburn, acid
regurgitation) in adults.
Reflux is the backflow of acid from the stomach into the gullet
(“foodpipe”), which may become inflamed and painful. This may
cause you symptoms such as a
painful burning sensation in the chest rising up to the throat
(heartburn) and a sour taste in the
mouth (acid regurgitation).
You may experience relief from your acid reflux and heartburn symptoms
after just one day of
treatment with Pantoprazole, but this medicine is not meant to bring
immediate relief. It may be
necessary to take the tablets for 2-3 consecutive days to relieve the
symptoms.
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
2.
WHAT YO

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole Mylan Pharmaceuticals 20 mg Gastro-resistant Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet
_ _
contains 22.550 mg of pantoprazole sodium sesquihydrate, equivalent to
20 mg of pantoprazole.
Excipient with known effect
Each tablet contains less than 23 mg of sodium, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Dark yellow film coated, oval,
approximately 4.3 mm x 8.4 mm,
biconvex tablet that is blank on
both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of reflux symptoms (e.g. heartburn, acid
regurgitation) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose is one gastro-resistant tablet (Pantoprazole
20 mg) per day. It might be
necessary to take the tablets for 2-3 consecutive days to achieve
improvement of symptoms. Once
complete relief of symptoms has occurred, treatment should be
discontinued.
The treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous
treatment, the patient should be
instructed to consult a doctor.
_ _
_Special populations _
No dose adjustment is necessary in elderly patients or in those with
impaired renal or liver function.
_Paediatric population_
Pantoprazole is not recommended for use in children and adolescents
below 18 years of age due to
insufficient data on safety and efficacy.
Method of administration
Pantoprazole 20 mg gastro-resistant tablets should not be chewed or
crushed, and should be
swallowed whole with liquid before a meal.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, substituted benzimidazoles
or to any of the excipients (listed
in section 6.1).
Co-administration of pantoprazole is not recommended with HIV protease
inhibitors for which
absorption is dependent on acidic intragastric pH such as atazanavir,
nelfinavir; due to significan